LensHooke X3 PRO Semen Quality Analyzer; LensHooke X3 PRO SE Semen Quality Analyzer

The LensHooke X3 PRO and X3 PRO SE are optical devices designed for automated human semen analysis, providing quantitative measurements of key sperm parameters for both professional and home-use settings. These devices leverage optical design, image analysis, and artificial intelligence to achieve substantial equivalence to predicate devices, offering an efficient method for assessing semen quality, though not a comprehensive fertility diagnosis.

Bonraybio Co., LTD. has received regulatory approval for its LensHooke X3 PRO and LensHooke X3 PRO SE Semen Quality Analyzers, with a determination of substantial equivalence to previously marketed predicate devices. These optical devices are designed for human semen analysis, providing automated, quantitative measurements of critical parameters including sperm concentration, total motility (progressive, non-progressive, and immotility), sperm morphology (normal forms), and pH value. This clearance permits the marketing of the devices, provided they adhere to standard regulatory controls such as annual registration, device listing, good manufacturing practices, and truthful labeling. Both models employ optical design, image analysis, and artificial intelligence to perform automated semen quality assessments. The LensHooke X3 PRO model is specifically intended for use in professional healthcare settings, such as clinical laboratories and point-of-care facilities, while the LensHooke X3 PRO SE is designed for over-the-counter use by individuals in a home setting. The substantial equivalence determination was based on comprehensive non-clinical and clinical performance evaluations, including accuracy and user performance studies, comparing the new analyzers against the existing LensHooke X1 PRO and X1 PRO SE Semen Quality Analyzers. It is important to note that neither device offers a comprehensive evaluation of a male’s fertility status.

AI Regulatory Concerns

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Jev reads the full FDA letter and returns calibrated concern probabilities per regulatory category. These are AI estimates, not regulatory advice.

• Q1. Given the "substantial equivalence" determination, what are the specific performance differences, if any, between the X3 PRO/SE and the X1 PRO/SE models, particularly regarding accuracy in diverse clinical samples?; How does the AI-driven image analysis account for inter-sample variability and potential artifacts, and what is its sensitivity and specificity in detecting subtle morphological abnormalities?; For the over-the-counter LensHooke X3 PRO SE, what specific user performance studies were conducted to ensure accurate and reliable results by lay users in a home environment?; Since the devices do not provide a "comprehensive evaluation of a male’s fertility status," what additional diagnostic parameters or follow-up tests are recommended for individuals with abnormal results from these analyzers?; What are the long-term data on the reproducibility and reliability of the automated pH measurement, and how critical is its accuracy for clinical interpretation of semen quality?